Dr. Francis Moussy
World Health Organisation
Essential Diagnostics List Secretariat
In May 2018, the World Health Organisation led the way in helping to prioritise diagnostics in global health by launching its Essential Diagnostics List (EDL). Dr. Francis Moussy, member of the EDL Secretariat at the WHO and currently leading projects to facilitate the development, access and use of in vitro diagnostics that are suitable for Low-and-Middle Income Countries (LMICs), was instrumental in bringing together this first list. In this Infectious Thoughts interview, we speak with Dr. Moussy about the substantial opportunities heralded by the EDL in reaching important global health goals through improving diagnostics worldwide, including boosting laboratories in resource-poor countries, encouraging innovation and funding towards new and improved diagnostic tools, and engaging nation-states to strengthen their health systems through improvements in diagnostics.
Last month, the World Health Organisation (WHO) launched its Essential Diagnostics List thus providing an essential boost to strengthening global health systems and both national and international coordination on disease diagnosis. What is the WHO's Essential Diagnostics List and what are the main global health challenges that it is seeking to address?
The Essential Diagnostics List (EDL) has been developed by the WHO as a tool to help countries priori-tise diagnostic needs. At the moment, the focus is on in vitro diagnostics rather than diagnostics in a larger sense (for example the list does not include x-rays or any other imaging equipment) however we might extend this to include a wider range of diagnostics in future.
In addition to direct aims such as supporting national governments, we are hoping that the EDL will have far reaching benefits such as helping companies as well as funders worldwide to understand pri-orities in terms of in vitro diagnostics, and bring much needed strengthening of laboratories in developing countries. Overall, we hope that the list will boost the development of new diagnostics – this could have further benefits such as stimulating the local diagnostics production and manufacturing.
The WHO's Essential Medicines List was launched four decades ago and significantly used worldwide since - what have been some of the factors that delayed a similar list for diagnostics and how have these been overcome?
I think that 40 years ago, we simply didn’t have that many diagnostics available and we didn’t hear a lot about in vitro diagnostics even at global health events - the focus was always on medicines and vaccines. It’s only recently that we have started talking a lot about diagnostics, spurred both by advances in technology and advocacy; in fact during this year’s World Health Assembly, many member states explicitly discussed the role and current gaps in diagnostics.
So in the past years, there has really been a growing awareness of the impact of diagnostics not only on healthcare but also in a wider
sense in terms of disease surveillance, monitoring and evaluation, … and this is really changing priorities. Several advocacy papers were arguing the case for such a list and there is a whole new movement around diagnostics which didn’t exits a few years ago.
How will the list be adapted in future as the global disease burden evolves and emergent threats appear? What review mechanisms does the WHO currently have in place to monitor and update the list?
Firstly, we are going to update the list once every year; this means that we have a fast cycle for renewing and expanding the list. In comparison, the Essential Medicines List is updated every two years. On the one hand, we will rely on our committee of 19 experts on in vitro diagnostics to help select the future areas we focus on. In addition, we will also invite comments and feedback from the wider community on the current list as well as suggestions for further areas to be considered for inclusion. In July 2018, we will issue a new call for submission of applications for categories of test to be considered for the second edition of the list. We are fully aware that in vitro diagnostics evolve faster than drug and vaccines, so we are getting input from many multiple sources and we will gather substantial intelligence which will allow us to adapt quite fast to new areas and be more agile.
One way to look at it would be to consider this first list as a single slice of a larger pie. In future years, we will be adding slices of the pie until the pie is complete – then we will have a steady state where we will just be making small adjustments, changes or additions.
Currently, the list contains just over 100 tests – about half of these are basic laboratory tests and the rest are very specialised tests. We focused initially on the diseases where we have a lot of evidence and data at WHO because recommendation for usable tests went through a rigorous and complex evidence-based evaluation process for grading and prioritisation – so in a sense this first list contains the low-hanging fruits which helped to get the list started and we are aiming to rapidly expand this to include other areas such as neglected tropical diseases, non-communicable diseases, anti-microbial resistance… These will be the other pieces of the pie which I mentioned and we will be expanding to these other areas through calls for applications which will be done once a year.
The Essential Diagnostics List will cover a wide range of countries, some of which can be faced with limited resources in terms of laboratory equipment and technician skills. How has the EDL taken this into consideration and has there been an emphasis on tests which can be easily undertaken and interpreted? How suited is the EDL to primary healthcare when resources are low? Can diagnostic companies do more?
The list is global but we realise that needs can be quite specific and resources constrained in low and middle-income countries, particularly at the primary health care level. This is why we felt it was important to distinguish in the EDL the diagnostics for primary health care and, in a separate category, the diagnostics for healthcare facilities where there are clinical laboratories.
The idea is that the list will help as a focal point for nations to improve their healthcare provision, but they will also be encouraged to take the lead, recognising specific needs and adapting the list to their own circumstances. At the same time, this means that there will be improved understanding of local needs which could encourage diagnostic companies to innovate accordingly.
However, companies also need to make a return on costly innovation so it will be important to provide the right incentives for this innovation. This requires a sustainable mechanism to incentivise companies to develop diagnostics for primary healthcare centres where they will probably not find a good return on investment – take the example of gonorrhoea: there are some diagnostic tools in use but, despite rapidly changing global needs, several companies have abandoned developing improved rapid point-of-care diagnostics for this disease due to the lack of prospects. One idea circulating in the global health diagnostics community has been the possibility of establishing an organisation for diagnostics similar to GAVI, which amongst others would help with securing procurement and take some of the pressure off companies. In any case, we need more discussion and ideas in this area so we can find sustainable ways of addressing diagnostic needs in particular for developing countries.
What other measures would the WHO encourage governments to implement around the Essential Diagnostics List - ranging from improving the skills and training of healthcare workers, ensuring the safety and authenticity of diagnostic kits, increasing resources towards laboratory medicine systems, accelerating the case for Universal Health Coverage...? Will there be targeted WHO support for this?
Absolutely; the list by itself could be useless if we don’t have around it the whole infrastructure to implement it: human resources, laboratories, effective procurement, access to reagents, etc. There are lots of things which need to be put in place around the list for countries to use it properly, so countries must get fully on board – im-proving infrastructure, labs and quality systems must be prioritised. This is why we said in the document that goes with the list that the countries will need to adopt and then adapt the list and we plan to really support the countries to develop their own national list based on this model global list. And we also expect the EDL to galvanise interest and support from external sources such as private sector and funders to help where needed.
In addition, we will be working internally at WHO to improve our wide range of documents and data relevant to helping countries establish their own plan for diagnostics and improving health care systems. For example, we will be updating our documents relating to laboratories. Also, the WHO also has a lot of information and data on topics such as human resources, quality control, laboratories... but at the moment all those are disseminated throughout the WHO and are not centralised so we are planning to create some repositories to centralise all this information related to laboratories and help countries to find what they need to have good labs and good diagnostics for their countries.
Improving access to medicines has up to now mostly been thought of in terms of the role of pharma in LMIC settings - will the EDL now ensure that diagnostics takes on its own important role in increasing access to treatment, sustainable healthcare provision or the provision of longitudinal patient data? Can diagnostics lead the way in forging new approaches to tackling diseases; for example by providing precise screening and improving vaccination campaigns, or offering robust data to tailor healthcare interventions as many diseases approach elimination?
This is definitely a big change that we are seeing and the role of diagnostics in these many goals is really being recognised and used. For example, in an outbreak such as Ebola, the first new products to be developed were diagnostics. Or in the case of anti-microbial resistance, I was recently in a meeting where it was discussed that developing new diagnostics must go hand-in-hand with developing new antibiotics in order to preserve this new antibiotic. It’s the same with vaccines, as we develop new vaccines we will also need new diagnostics.
The community is becoming more and more aware of the crucial role of diagnostics and the list will contribute to developing this awareness. However, an important bottleneck remains the urgent need to improve laboratories globally; we are aware that the world has not made a lot of progress on lab strengthening and we hope that the EDL and all the processes around it will help this so that diagnostics can be used to their full potential in helping patients, supporting disease elimination goals and public health monitoring.
How can the tropical diseases and global health community at large support your effort?
As I mentioned, the EDL will be updated and adjusted every year. We welcome comments and applications for inclusion of additional diagnostics to this list; a call will be opened in July 2018. Organisations such as the International Society for Neglected Tropical Diseases can help to bring to light the priority diagnostics which need to be included.
The process of including tests in the list has been very data- and evidence-driven. We are aware that for many NTDs, there is not a lot of evidence, compared with TB or HIV where there have been many more studies. So for some of the NTDs, data and information will be lacking but we are still looking to consider these and will develop processes to deal with this lack of information. Discussion and contributions from experts in these fields will be very important.
For more information or to submit an application to add a diagnostic test to the WHO’s Essential Diagnostics List, please contact:
or Marianne Comparet
International Society for Neglected Tropical Diseases